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Cobimetinib Side Effects

For the Consumer

Applies to cobimetinib: oral tablet

Along with its needed effects, cobimetinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cobimetinib:

More common
  • Abdominal or stomach pain or tenderness
  • bleeding gums
  • blurred vision or any other change in vision
  • chest discomfort or pain
  • chills
  • clay colored stools
  • coughing up blood
  • dark urine
  • decreased appetite
  • difficulty in breathing or swallowing
  • dizziness
  • faintness
  • fast irregular or pounding heartbeat
  • fever
  • headache
  • increased menstrual flow or vaginal bleeding
  • increased sensitivity of the skin to sunlight
  • itching or skin rash
  • loss of appetite
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea and vomiting
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • redness or other discoloration of the skin
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
  • severe sunburn
  • slow or fast heartbeat
  • swelling of the feet or lower legs
  • unusual tiredness or weakness
  • yellow eyes or skin

Some side effects of cobimetinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acne or pimples
  • diarrhea
  • nausea
  • swelling or inflammation of the mouth
  • vomiting

For Healthcare Professionals

Applies to cobimetinib: oral tablet

General

The most commonly reported adverse reactions (more than 35%) were increased creatinine, increased CPK, lymphopenia, increased AST, increased alkaline phosphatase, increased ALT, hypophosphatemia, anemia, increased gamma-glutamyltransferase, diarrhea, photosensitivity reactions, hypoalbuminemia, nausea, and hyponatremia.[Ref]

Renal

Very common (10% or more): Increased creatinine (99.6%)[Ref]

Musculoskeletal

Very common (10% or more): Increased CPK (79%)[Ref]

Hepatic

Very common (10% or more): Increased AST (73%), increased alkaline phosphatase (71%), increased ALT (68%), increased gamma-glutamyltransferase (65%)
Frequency not reported: Increased total bilirubin[Ref]

Hematologic

Very common (10% or more): Lymphopenia (73%), anemia (69%), thrombocytopenia (18%)[Ref]

Metabolic

Very common (10% or more): Hypophosphatemia (68%), hypoalbuminemia (42%), hyponatremia (38%), hyperkalemia (26%), hypokalemia (25%), hypocalcemia (24%)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (60%), nausea (41%), vomiting (24%), stomatitis (14%)[Ref]

Dermatologic

Very common (10% or more): Photosensitivity reactions (47%), acneiform dermatitis (16%), alopecia (15%), hyperkeratosis (11%), erythema (10%)
Frequency not reported: Rash[Ref]

Other

Very common (10% or more): Pyrexia (28%), hemorrhage (13%), chills (10%)[Ref]

Reported hemorrhage cases included various types of hemorrhages (rectal, hemorrhoidal, gastrointestinal tract, uterine, vaginal, pulmonary, cerebral, subarachnoid, ocular, eye, conjunctival, retinal; reproductive system); melena, hematemesis; hematochezia; gingival bleeding; metrorrhagia; hemorrhagic ovarian cyst; menometrorrhagia; menorrhagia; hemoptysis; subgaleal hematoma; hematuria; epistaxis; contusion; traumatic hematoma; ecchymosis; purpura; and nail bed bleeding.[Ref]

Cardiovascular

Very common (10% or more): Decreased LVEF (26%), hypertension (15%)[Ref]

Ocular

Very common (10% or more): Serous retinopathy (26%), impaired vision (15%), chorioretinopathy (13%), retinal detachment (12%)
Uncommon (0.1% to 1%): Retinal vein occlusion[Ref]

Oncologic

Common (1% to 10%): Cutaneous squamous cell carcinoma/keratoacanthoma, basal cell carcinoma
Uncommon (0.1% to 1%): Second primary melanoma, non-cutaneous malignancies[Ref]

References

1. "Product Information. Cotellic (cobimetinib)." Genentech, South San Francisco, CA.

Some side effects of cobimetinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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